ClimAIr: AI to Assess the Impact of Pollution and Climate on Respiratory Health in Europe

NCT07107009 | Not Yet Recruiting DMC

• 1 other identifier: 101156799-2 ClimAIr
• Study Type: observational
• Target: 1,906
• Locations: 0 countries
• Sites: N/A

Brief Summary

The ClimAIr project will expand the evidence-based understanding of climate change, air pollution, and non-communicable respiratory diseases by using Artificial Intelligence (AI) tools. It will gather data on greenhouse gases levels and disaster risks, information on serious air pollutants and respiratory diseases' prevalence. The AI powered tools will be employed to generate better intervention methods and improve public health outcomes. Federated Learning (FL) will be used to develop AI models to protect patients' privacy. By raising public awareness and delivering the ClimAIr tool - specifically designed to health workers, urban planners and policy makers - the project aims to influence policy decisions, promote healthier environments, and reduce respiratory diseases in Europe, which will be tested and validated the ClimAIr tool in specific municipalities that are part of the project. ClimAIr draws on a consortium of 21 partners from 15 European countries, including carefully selected health centres across Europe - in Spain, Luxembourg, Ukraine, Italy, France, Germany, Greece, Romania and Poland - focused on respiratory diseases, which will provide disease data and explore metabolic routes of the studied contaminants/diseases. ClimAIr is composed of an interdisciplinary team formed by research centres, ethical AI and modelling experts, SSH specialists, municipal governance, and a Communication \& Dissemination (C\&D) expert team dedicated to achieving and spread the results of the project.

Conditions

Allergic Rhinitis; Asthma

Keywords

Air contamination; Air pollutants; Non-communicable respiratory diseases; Climate change; ClimAIr

Outcome Measures

Primary Outcomes (2)

• Mean Symptom Score of Allergic Rhinitis Patients by Environmental Exposure

  Mean allergic rhinitis symptom scores retrieved from electronic health records (EHR), stratified by environmental exposure levels (pollutants and climate factors), using the Observational Medical Outcomes Partnership (OMOP) common data model.

  Retrospective data collected over a 3-year period prior to study enrollment.

• Proteomic Biomarker Levels (NPX) by Environmental Exposure

  Proteomic profiles measured using Olink® assays in serum and nasal lavage of allergic rhinitis patients, stratified by environmental exposure.

  Samples collected prospectively between months 10 and 15 (October-March, out-of-pollen season).

Secondary Outcomes (3)

• SO1: Effect of air pollution on adaptive immune responses to allergenic pollen

  Sample collection and analysis performed prospectively between months 10 and 24.

• SO1: Proliferative responses of allergen-specific lymphocytes to pollen exposed to pollution

  Assays conducted on samples collected between months 10 and 24.

• SO1: Cytokine release from allergen-specific lymphocytes in response to polluted pollen

  Analysis performed between months 10 and 24, post-sample collection.

Study Arms (3)

P01 - General Exposure Cohort

\>200 AR patients per environmental condition. Includes patients exposed to various air pollutants, aiming to detect deleterious clinical effects.

P02 - Omics Synergistic Subgroup

Subgroup of 20 patients per environmental condition from P01. Selected based on exposure to multiple pollutants with observed synergistic effects on omics parameters.

S01 - Allergen-Specific Immune Response Subgroup

Subgroup of 25 patients per pollution condition from P01. Selected for in vitro assays to evaluate proliferation of peripheral allergen-specific lymphocytes in response to polluted pollen exposure.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pacients with 3-year history of chronic rhinitis symptoms during the corresponding pollen seasonp ositive SPT and serum allergen-specific IgE \>0.35 kUA/L.

You may qualify if:

• Patients with health insurance based in Malaga, Milan, Luxembourg, Thessalonikki, Lodz, Berlin, Toulousse, Chervnivtsi and Brasov (the places where environmental/climate information will be obtained from, only one recruitment place for partner).
• year history of chronic rhinitis symptoms during the corresponding pollen season, while residing in the same household AND attending the same school/college or holding the same job position.
• Positive SPT and serum allergen-specific IgE \>0.35 kUA/L. The pollen species driving the nasal symptoms will be Olea europaea, Phleum pratense or Betula pendula.
• Patients can be sensitized to other aeroallergens if the nasal symptoms occur exclusively or aggravate unequivocally during the pollen season of the three allergens of interest.

You may not qualify if:

• Lack of reliable information in e-health records, allergen immunotherapy (any allergen) during the previous 5 years, systemic immunosuppressants or biologicals in the previous six months, chronic rhinosinusitis, and severe systemic conditions.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Theramed Healthcare SRL (Romania): collaborator
• Centre Hospitalier Universitaire de Toulouse, FRANCE: collaborator
• Charite-Universitaetsmedizin Berlin (Germany): collaborator
• Aristotelio Panepistimio Thessalonikis (Greece): collaborator
• Uniwersytet Medyczny w Lodzi (Poland): collaborator
• Universita degli Studi di Milano (Italy): collaborator
• Bukovinian State Medical University (Ukraine): collaborator
• Luxembourg Institute of Health (Luxembourg): collaborator
• Andaluz Health Service: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood : for serum ,DNA isolation and cellular assays. Nasal lavage: Bilateral lavage using isotonic saline by Naclerio method. Skin tape strips: 16 consecutive D-Squame tape strips applied to forearm for skin tissue sampling. Analyses performed on samples include: Proteomics (Olink®) on serum and nasal lavage supernatant Targeted metabolomics (LC-MS and GC-MS) on serum and nasal lavage DNA methylation profiling (Illumina EPIC array) from PBMC DNA Flow cytometry of PBMC cultured with pollen to assess lymphocyte proliferation and antibody production Multiplex ELISA for cytokine quantification in PBMC culture supernatants Microbiota analysis (16S, 18S, ITS2 sequencing) from nasal lavage pellets and skin tape strips

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Central Study Contacts

Ibon Eguiluz Gracia, MD, PhD

CONTACT

+34 951 291 073; iboneguiluz@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12